
Test Item | Specification limits | Test Result |
Characteristics | ||
Appearance | White or yellowish-white powder | White powder |
Solubility | Very slightly soluble in water, slig htly soluble in alcohol. | Very slightly soluble in water, slightly soluble in alcohol. |
Identification | ||
A: Melting point | 199-203℃ | 199-200℃ |
B:Specific absorbance | Max .287nm:240-250 | 244 |
C:IR-spectrum | Complies with reference spectrum | Complies with reference spectrum |
D: Chemical reaction | Green fluorescence at 365nm | Green fluorescence at 365nm |
Appearance of solution | Not more intensely colored than Reference Solution BY7 | Less intensely colored than Reference Solution BY7 |
Related substances | ||
Method A by HPLC: | ≤0.1% | Not detected |
Any single impurity | ≤0.1% | <0. 1% |
Total impurities | ≤0.2% | <0.2% |
Method B by HPLC: | ≤0.1% | <0.1% |
Total impurities | ≤0.2% | <0.2% |
Heavy metals | ≤20ppm | <20ppm |
Residual methanol | ≤3000ppm | Not detected |
Residual DMSO | ≤5000ppm | Not detected |
Impurity K (aniline) by GC | ≤5ppm | <5ppm |
Loss on drying | ≤1.0% | 0.4% |
Sulphated ash | ≤0.1% | 0.02% |
Assay | 98.5-101.0% | 99.3% |
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